LIBERATOR/STROLLER— 510(k) K760787

Name: FDA 510(k) clearance K760787
Creator: U.S. Food and Drug Administration
Published: 1976-10-22

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

FDA 510(k) clearance K760787 for LIBERATOR/STROLLER, Substantially Equivalent on 1976-10-22. Applicant: Burditt & Calkins-Siemens-Elema. Device class: 2.

Clearance details

Applicant: Burditt & Calkins-Siemens-Elema
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1976-10-06
Decision date: 1976-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYJ

view all

K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)2013-07-19
K113767 — MOUNTED MEDICAL OXYGEN SYSTEM2012-06-29
K103324 — PRECISION LIQUID OXYGEN SYSTEM2011-04-21
K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-32010-08-20
K081779 — GOLOX-932008-09-19

More clearances from Burditt & Calkins-Siemens-Elema

view all

K833519 — PULSE GENERATOR MODEL 6881984-01-30
K833155 — RAYDEN MEDICAL MINI PULSE VOLUME RECORD1984-01-26
K830344 — SIEMENS-ELMA PULSE GENERATOR #7181983-05-27
K823435 — MON-A-THERM MYOCARDIAL TEMP. SENSOR1982-12-30
K823591 — AMEDA HAND BREAST PUMP1982-12-28

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.